Evgen Pharma receives UK approval for breast cancer trial

17 August 2016 • Author: Evgen Pharma

Following its approval from the UK’s regulatory agency, Evgen Pharma, a clinical stage drug development company, will commence their STEM Phase II clinical trial for its breast cancer drug, SFX-01, to investigate its efficacy in combination with different hormone-based therapies, in 60 metastatic breast cancer patients, whose cancer cells are estrogen-receptor positive (ER).

Patient recruitment will begin in the UK at Manchester’s Christie NHS Foundation Trust following Research Ethics approval, which is expected during the coming weeks. Further regulatory and Research Ethics approvals are also expected shortly at various sites across Europe in this multi-centre study.

Trial objectives

The primary objectives of the STEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer) trial are to use tumour imaging to evaluate safety and efficacy in patients starting to become resistant to mainstream hormone therapy. Patients will be enrolled into one of three study arms (SFX-01 in combination with either aromatase inhibitors, tamoxifen or fulvestrant) based on their current therapy.

Hormone-independent stem cells

One proposed mechanism for the generation of resistance to hormone therapy is via the proliferation of hormone-independent breast cancer stem cells. Such cells are known to proliferate during treatment with hormonal agents and it is thought they could have the effect of repopulating the tumour to render it hormone-independent. Earlier work with xenograft models suggests that SFX-01 has the effect of reducing the number of hormone-independent cancer stem cells.

SFX-01 is a synthetic and stabilised version of the naturally occurring plant compound sulforaphane, a known anti-cancer agent and neuro-protective.

Dr Stephen Franklin, CEO of Evgen Pharma, commented, “Many therapies used in cancer ultimately fail as patients develop resistance – one hypothesis is that this resistance is driven by cancer stem cells which, unlike a mature cancer cell, do not respond to current standards of care. Our excitement with SFX-01 is that it targets the cancer stem cell population and therefore has the potential to improve the efficacy and longevity of a range of drugs used in cancer therapy – both approved drugs and those in clinical development.”

“I would also like to take this opportunity to thank Dr Sacha Howell and colleagues at the Christie NHS Foundation Trust and the Cancer Research UK Manchester Institute for their steadfast support and encouragement.”